HealthyNCT03316612
The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism
A study testing Vaccinium Myrtillus L. extract in people with Healthy, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic diseases. The findings of previous experiments suggested that the extracts from polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized double-blind trial, aims to study the effect of Vaccinium Myrtillus L. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vaccinium Myrtillus L. extract
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-35 years of age
- Able to give informed connect
Who cannot join
- Pregnancy
- Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
- Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
- Evidence of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liegang Liu, MD, PhD, +86-27-83650522, liegangliu@gmail.com
Liangkai Chen, MD
About this study
Official title: The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic diseases. The findings of previous experiments suggested that the extracts from polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized double-blind trial, aims to study the effect of Vaccinium Myrtillus L. natural extracts on AGEs and human metabolism. Firstly, we will investigate the efficacy of Bilberry extracts on lowering the levels of advanced glycation end-products (AGEs). Secondly, we will conduct 16S rRNA sequencing and ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) detection to explore the role of bilberry extracts on gut microbiota as well as metabolites.
- Conditions
- Healthy
- Being tested
- Vaccinium Myrtillus L. extract, Placebo
- Keywords
- Advanced Glycation End Products, Metabolites, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccinium Myrtillus L. extractDietary supplement
Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
PlaceboDietary supplement
Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Ingredients: Vaccinium Myrtillus L. extracts, and excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent)
Brown oval tablet, 650mg per tablet with 150mg Vaccinium Myrtillus L. extracts, twice a day, 2 tablets each time.
The intervention period is about 3 months. Receives: Dietary Supplement: Vaccinium Myrtillus L. extract |
| Placebo group | Placebo comparator | Ingredients: excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent)
Brown oval tablet without Vaccinium Myrtillus L. extracts, 650mg per tablet, twice a day, 2 tablets each time.
The intervention period is about 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma AGEs levels
Using UPLC-MS/MS to detect plasma AGEs (including CML, CEL, MG-H1).
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in urinary AGEs levels
Using UPLC-MS/MS to detect urinary AGEs (including CML, CEL, MG-H1).
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in plasma sRAGE levels
sRAGE (soluble Receptor for Advanced Glycation End-products)
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in transcription levels of RAGE and AGER1
Extract and isolate peripheral blood mononuclear cells (PBMC) from participants. Using the PCR technology to detect the mRNA levels of RAGE and AGER1.
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in gut microbiota
Measured: At 0 week (baseline), 10th week.
Changes in plasma metabolites
Measured: At 0 week (baseline), 4th week, 10th week.
Secondary outcomes (6)
Changes in skin AGEs levels
Using AGE Reader to quickly and noninbasively measure skin AGEs by means of fluorescence techniques.
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in body weight
Measured: At 0 week (baseline), 4th week, 10th week.
Change in body composition (body fat mass and lean mass)
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in blood lipids profile
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in pro-inflammatory markers
Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α
Measured: At 0 week (baseline), 4th week, 10th week.
Changes in fecal short chain fatty acids (SCFA)
Measured: At 0 week (baseline), 10th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start10 Nov 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316612
- Sponsor's protocol ID
- C01-201611090005
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT03316612
- Acronym / sponsor ID
- C01-201611090005
- Conditions
- Healthy
- Keywords
- Advanced Glycation End Products, Metabolites, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic diseases. The findings of previous experiments suggested that the extracts from polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized double-blind trial, aims to study the effect of Vaccinium Myrtillus L. natural extracts on AGEs and human metabolism. Firstly, we will investigate the efficacy of Bilberry extracts on lowering the levels of advanced glycation end-products (AGEs). Secondly, we will conduct 16S rRNA sequencing and ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) detection to explore the role of bilberry extracts on gut microbiota as well as metabolites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Vaccinium Myrtillus L. extractIngredients: Vaccinium Myrtillus L. extracts, and excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent) Brown oval tablet, 650mg per tablet with 150mg Vaccinium Myrtillus L. extracts, twice a day, 2 tablets each time. The intervention period is about 3 months. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboIngredients: excipients (cellulose microcrystalline, mannitol, silica, magnesium stearate, coating agent) Brown oval tablet without Vaccinium Myrtillus L. extracts, 650mg per tablet, twice a day, 2 tablets each time. The intervention period is about 3 months. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18-35 years of age
- Able to give informed connect
Key exclusion criteria (4 listed)
- Pregnancy
- Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
- Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
- Evidence of drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccinium Myrtillus L. extractTwice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Dietary supplement | Intervention group |
| PlaceboTwice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Dietary supplement | Placebo group |
Primary outcome
Changes in plasma AGEs levels
Time frame: At 0 week (baseline), 4th week, 10th week.
Using UPLC-MS/MS to detect plasma AGEs (including CML, CEL, MG-H1).
Changes in urinary AGEs levels
Time frame: At 0 week (baseline), 4th week, 10th week.
Using UPLC-MS/MS to detect urinary AGEs (including CML, CEL, MG-H1).
Changes in plasma sRAGE levels
Time frame: At 0 week (baseline), 4th week, 10th week.
sRAGE (soluble Receptor for Advanced Glycation End-products)
Changes in transcription levels of RAGE and AGER1
Time frame: At 0 week (baseline), 4th week, 10th week.
Extract and isolate peripheral blood mononuclear cells (PBMC) from participants. Using the PCR technology to detect the mRNA levels of RAGE and AGER1.
Changes in gut microbiota
Time frame: At 0 week (baseline), 10th week.
Changes in plasma metabolites
Time frame: At 0 week (baseline), 4th week, 10th week.
6 secondary outcomes
Changes in skin AGEs levels
Time frame: At 0 week (baseline), 4th week, 10th week.
Changes in body weight
Time frame: At 0 week (baseline), 4th week, 10th week.
Change in body composition (body fat mass and lean mass)
Time frame: At 0 week (baseline), 4th week, 10th week.
Changes in blood lipids profile
Time frame: At 0 week (baseline), 4th week, 10th week.
Changes in pro-inflammatory markers
Time frame: At 0 week (baseline), 4th week, 10th week.
Changes in fecal short chain fatty acids (SCFA)
Time frame: At 0 week (baseline), 10th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccinium Myrtillus L. extract in people with Healthy, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liegang Liu, MD, PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma AGEs levels (time frame: At 0 week (baseline), 4th week, 10th week.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.